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Search / Trial NCT07020702

ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jun 5, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cardiomyopathies Sudden Death Myocardial Infarction

ClinConnect Summary

The EP-SCOPE trial is a study that is looking at how to better predict the risk of life-threatening heart rhythm problems, known as ventricular arrhythmias, in patients with certain types of heart disease. Specifically, it focuses on individuals who have a weaker heart function, indicated by a measurement called left ventricular ejection fraction (LVEF) of 50% or less. These patients might also have other risk factors for these dangerous heart rhythms but do not currently qualify for a device called an implantable cardioverter defibrillator (ICD), which helps prevent sudden cardiac death.

To be eligible for this study, participants need to be between the ages of 65 and 79 and must have heart disease with a LVEF between 35% and 50%, along with at least one risk factor. Alternatively, patients with a LVEF of 35% or less who are also recommended for a specific heart treatment called cardiac resynchronization are also eligible. During the trial, participants will undergo detailed testing of their heart's electrical activity to help understand their risk level better. It's important to note that certain individuals, such as those with severe heart issues or other specific conditions, will not be able to participate. Overall, this study aims to improve how we assess heart risks in patients who need careful monitoring.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient with cardiomyopathy with 35%\<LVEF\<50% and at least one risk factor
  • Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation
  • Exclusion Criteria:
  • Patients who are minors or aged 80 or over
  • Patients with unstable coronary artery disease
  • Myocardial infarction less than 40 days old
  • Coronary revascularisation \<90 days
  • Patients with intracardiac thrombus
  • Patients with a mechanical heart valve
  • Patient implanted with an automatic defibrillator
  • Patient life expectancy \<1 year
  • Pregnant or breast-feeding women
  • Anti-arrhythmic drugs other than beta-blockers and amiodarone

About University Hospital, Bordeaux

The University Hospital of Bordeaux is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the institution integrates cutting-edge scientific inquiry with patient care, fostering an environment that encourages collaboration among multidisciplinary teams. With a commitment to improving treatment outcomes and enhancing patient safety, the University Hospital of Bordeaux plays a pivotal role in the development of new therapies and medical technologies, contributing significantly to the global medical community.

Locations

Clermont Ferrand, , France

Saint Etienne, , France

Pessac, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported